RECRUITINGOBSERVATIONAL

Paclitaxel-induced Polyneuropathy in Breast Cancer: Early Detection, Risk Factors, Quality of Life and Lifestyle Outcomes

Chemotherapy(paclitaxel)-induced Polyneuropathy in Breast Cancer As Part of the REBECCA Project (REsearch on BrEast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data)

About This Trial

This is a single center prospective observational cohort study that aims to: * examine and identify possible risk and susceptibility factors for the incidence and progression of chemotherapy-induced polyneuropathy (CIPN) in female patients primarily operated for early non-metastatic breast cancer who will receive adjuvant chemotherapy containing paclitaxel * test different neurophysiological methods for early detection of CIPN * explore changes that underlie the development of CIPN in relation to clinical presentations, neurophysiological assessment, including measures of small nerve fiber dysfunction, and possible biochemical, metabolic and genetic associations * explore the effects of CIPN in the patient's lifestyle and quality of life for up to 12 months after the initiation of treatment

Who May Be Eligible (Plain English)

Who May Qualify: - Female patients - Age of ≥ 18 years - Newly operated primary breast cancer without metastatic disease receiving adjuvant chemotherapy containing paclitaxel - No prior chemotherapy other than cyclophosphamide and epirubicin - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 - Written willing to sign a consent form - Able to communicate with investigators, participate in testing and comply with the requirements of the study-protocol Who Should NOT Join This Trial: - Have received drugs suspected/known to cause peripheral neuropathy - Have history of acquired or inherited neuropathy or other genetic disease with increased tendency to develop neuropathy - Have known disturbed glucose metabolism, either diabetes mellitus or impaired glucose tolerance - Have moderate to severe kidney, liver, lung or heart disease - Have known symptomatic or other advanced spinal stenosis - Have known autoimmune conditions (where your immune system attacks your own body) that potentially cause or contribute to neuropathy - Have known HIV or active HBV or HCV infections - Have known paraneoplastic syndrome - Have known alcohol abuse - Have known pregnancy or nursing Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Female patients * Age of ≥ 18 years * Newly operated primary breast cancer without metastatic disease receiving adjuvant chemotherapy containing paclitaxel * No prior chemotherapy other than cyclophosphamide and epirubicin * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Written informed consent * Able to communicate with investigators, participate in testing and comply with the requirements of the study-protocol Exclusion Criteria: * Have received drugs suspected/known to cause peripheral neuropathy * Have history of acquired or inherited neuropathy or other genetic disease with increased tendency to develop neuropathy * Have known disturbed glucose metabolism, either diabetes mellitus or impaired glucose tolerance * Have moderate to severe kidney, liver, lung or heart disease * Have known symptomatic or other advanced spinal stenosis * Have known autoimmune disease that potentially cause or contribute to neuropathy * Have known HIV or active HBV or HCV infections * Have known paraneoplastic syndrome * Have known alcohol abuse * Have known pregnancy or nursing

Treatments Being Tested

DEVICE

Garmin smartwatch

* Physical activity (Activity sessions, type and length of activity, activity intensity estimations) * Meal detection and meal characteristics (accelerometry and gyroscope data) * Oxygen saturation (pulse oximetry) * Number of steps (pedometer) * Stress level indicators (based on heart-rate analytics) * Sleep patterns (sleep and wake-up time, sleep quality)

OTHER

REBECCA Mobile application

* GPS positioning (daily location change patterns through pathway analysis and Point-of-interest analysis based on type-of-location automatic detection) * Self-reports from patients and companions reports on mental and physical health, as well as periodic quality of life evaluations3 * Patient self-uploaded pictures of meals (for evaluation of nutritional habits) and living environment stressors (for evaluation of living environment and self-perceived stressor analysis)

OTHER

REBECCA PC plug-in

* the developed plug-in monitors online activity, collecting anonymized data from web-browsers (Chrome) and social media (Facebook, Youtube and Instagram). * These are relevant to current and historical data on: i) keywords in searches, ii) types of websites visited, iii) reactions to posts, iv) participation in online groups, v) types of bookmarked websites

Locations (1)

Karolinska University Hospital

Solna, Stockholm County, Sweden